PATIENT INFORMATION LEAFLET

Transcription

1 HAMAZINC cream For topical use. PATIENT INFORMATION LEAFLET Active substance(s): Each 1 gram cream contains 53.5 mg hamamelis virginiana distillate and mg zinc oxide. Excipient(s): Methylparaben(E218), ethylparaben (E214), propylparaben (E216), cetomagrogol 1000, propylene glycol, cetostearyl alcohol, liquid paraffin, white paraffin and deionized water. Read this PATIENT INFORMATION LEAFLET carefully before you start using this medicine, because it contains important information for you. This medication is intended to treat a mild illness with the advice of your pharmacist without obtaining a prescription and without the help of a doctor. However, you still have to use HAMAZINC carefully so that you can get the best results Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. If you go to a doctor or hospital during the use of this medicine, inform your doctor about this. Follow the instructions in this leaflet exactly. Do not use higher or lower doses than the dose which was recommended for you. What is in this leaflet? 1. What HAMAZINC is and what it is used for 2. Before you use HAMAZINC 3. How to use HAMAZINC 4. Possible side effects 5. How to store HAMAZINC 1. What HAMAZINC is and what it is used for? HAMAZINC is a topical cream containing hamamelis virginiana distillate and zinc oxide which is available in 30 g, 60 g and 90 g aluminum tubes. The Hamamelis virginiana aqueous extract present in HAMAZINC composition has astringent (tissue constrictor), local hemostatic (stops bleeding) and anti-inflammatory (reduces inflammation) activities. Following skin injuries, the tissue constrictor effect provides tissue thickening by causing coagulation of skin proteins at the injury site. The local hemostatic effect reduces bleeding time and accelerates clotting at the injury site following a skin injury. It relieves signs and symptoms of inflammation of the skin with its anti-inflammatory activity.

2 Zinc oxide reduces inflammation and tissue death in damaged and injured skin and accelerates wound healing in the injury site by increasing skin cell growth. HAMAZINC is used for, - Diaper rash in babies and young children - Maintenance treatment for diaper rash aggravating due to fungal infections or bacterial infections - First and second degree burns/ sunburn - Superficial skin lesions (injuries) including scratches and cuts - Care and prevention of cracked nipples in nursing mothers - Care and protection of dry, cracked, split skin (including skin of the elderly and treatment of diabetic foot) - Additional treatment of skin diseases that become evident with tissue disorders such as redness, itching, discharging, crusting due to various causes, discharging skin lesions such as skin injury due to rubbing on the skin or fungus-like microbes and sudden onset of wounds, especially leg wounds and pressure sores due to prolonged immobility in combination with other treatments. 2. Before you use HAMAZINC Do not use HAMAZINC in the following conditions: If you are allergic to any of the ingredients of HAMAZINC. TAKE SPECIAL CARE with HAMAZINC in the following conditions: Contact of HAMAZINC with eyes should be avoided. In case of contact with eyes, eyes should be washed with plenty of water. If current complaints persist or worsen despite using HAMAZINC, a doctor should be consulted. Please consult your doctor, even if these statements were applicable to you at any time in the past. Using HAMAZINC with food and drink: There is no special indication regarding using HAMAZINC with food and drink. Pregnancy Ask your doctor or pharmacist for advice before taking the medicine. For Hamamelis virginiana, no clinical data on exposed pregnancies are available. For zinc oxide, no clinical data on exposed pregnancies are available. Animal studies are also unavailable. Caution should be used if HAMAZINC is to be used during pregnancy. If you notice that you are pregnant during treatment, please consult your doctor or pharmacist immediately. Breastfeeding Ask your doctor or pharmacist for advice before taking the medicine. It is not known whether Hamamelis virginiana passes into human milk. Excretion of Hamamelis virginiana into milk in animals has not been investigated. It is not known whether zinc oxide passes into human milk. Consult your doctor about using HAMAZINC during lactation.

3 Effects on ability to drive and use machines: There is no known effect on driving and using machines. Important information about some of the ingredients of HAMAZINC Local skin reactions (skin inflammation caused by contact directly with irritant or allergic substances) and skin irritation may rarely occur due to propylene glycol and cetostearyl alcohol contents. The methylparaben (E218), ethylparaben (E214), propylparaben (E216) contents of HAMAZINC may cause allergic (potentially delayed) reactions. Using with other medicines No interaction of HAMAZINC with other medicinal products via the topical route was reported. Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or nonprescription medicine. 3. How to use HAMAZINC? Instructions for appropriate method and dose/frequency of administration: HAMAZINC is applied few times a day to the lesion area. There is no time limitation to using HAMAZINC. Route and method of administration: HAMAZINC is applied to the lesion area as a thin layer. Lesion area can be covered with gauze bandage following application, if necessary. For nipple care of nursing mothers, HAMAZINC is applied to the nipples after each breastfeeding. Different age groups: Use in children: Use in elderly: Special Populations Kidney/Liver failure: If you have the impression that the effect of HAMAZINC is too strong or too weak, talk to your doctor or pharmacist. If you have used more HAMAZINC than you should: If you may have taken more HAMAZINC than you should, talk to a doctor or pharmacist. If you forget to use HAMAZINC: Do not use a double dose to make up for a forgotten dose. If you stop using HAMAZINC: No effect is expected.

4 4. Possible side effects Like all medicines, side effects can occur in people sensitive to the contents of HAMAZINC. If any of the following occur stop using HAMAZINC and IMMEDIATELY inform your doctor or go to the nearest emergency department. Swelling of hands, feet, ankles, face, lips or especially swelling of mouth and throat causing difficulty in breathing These are very serious side effects. If you have any of them, this means you have serious allergy for HAMAZINC. You may need emergency medical care or hospitalization. All of these very serious side effects occur very rarely. Side effects are classified by the following categories: Very common: may be seen at least 1 in 10 patients Common: may be seen less than one in 10 patients but more than one in 100 patients Uncommon: may be seen less than one in 100 patients but more than one in 1000 patients Rare: may be seen less than one in 1000 patients but more than one in patients Very rare: may be seen less than one in patients Unknown: it cannot be estimated from the available data Uncommon (may be seen less than one in 100 patients but more than one in 1000 patients) Exanthema (uniform, spontaneous skin rash that resolves without sequela, symptomatic skin rash) Skin irritation, itching, burning and stinging sensation, Erythema (skin redness) Dry skin. Unknown (it cannot be estimated from the available data) Allergic reaction, Contact dermatitis (skin inflammation caused by contact directly with irritant or allergic substances), eczema (skin disease that become evident with tissue disorders such as redness, itching, discharging, crusting due to various causes), Urticaria (hives, allergic skin rash) Angioneurotic edema (allergic skin disorder presenting with large and painless swelling like hives which is restricted to a certain region under the skin) If you notice any side effects not mentioned in this leaflet inform your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via clicking Reporting of Drug Side Effects icon on the website or Turkish Pharmacovigilance Center (TUFAM) by calling the phone number for side effects reporting line. By reporting side effects, you can help provide more information on the safety of this medicine.

5 5. How to store HAMAZINC Keep in the original package and out of the reach and sight of children. Store in room temperature under 25 C. Use in accordance with expiry date. Do not use HAMAZINC after the expiry date which is stated on the tube or package. Do not use HAMAZINC if you notice any damage to the product and/or package. Marketing authorization Holder: Berko İlaç ve Kimya San. A.Ş. Yenişehir Mah. Özgür Sok. No: Ataşehir/İstanbul (Pbx) (Fax) Manufacturer: Berko İlaç ve Kimya San. A.Ş. Adil Mah. Yörükler Sok. No: 2 Sultanbeyli/ İstanbul (Pbx) (Fax) This patient information leaflet was approved on 31/12/2015.